Hepatitis C Treatment Access Working Group

July 27, 2015

Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-2390-P
P.O. Box 8016
Baltimore, MD 21244-8016
RE: Medicaid and Childrens Health Insurance Program (CHIP) Programs; Medicaid Managed Care,
CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and
Revisions Related to Third Party Liability, Proposed Rules
The Hepatitis C (HCV) Treatment Access Working Group welcomes the opportunity to respond to
the Medicaid and Childrens Health Insurance Program (CHIP) Programs; Medicaid Managed
Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and
Revisions Related to Third Party Liability proposed rule. We are writing on behalf of the
undersigned organizations and advocates who are dedicated to the elimination of hepatitis C
(HCV). This proposed rule presents a tremendous opportunity to address practices that impact
the extent which the 578,0001 Medicaid beneficiaries who are living with HCV have access to
care and treatment. Stronger MCO standards are necessary to modernize longstanding Medicaid
beneficiary protections, and promote efficient and equitable service delivery practices.
Furthermore, beneficiary protections that mirror the Affordable Care Acts (ACA) consumer
protections will help to support a more congruous American health care system, and achieve the
goals of the DHHS Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis. To this
end, we urge CMS to consider the comments below as it contemplates a final rule.
NETWORK ADEQUACY STANDARDS ( 438.68)
While we support the proposed mandate that states develop network adequacy standards for
MCOs operating within their jurisdictions, we strongly urge CMS to increase the minimum
requirements noted in the managed care proposed rule. We urge CMS to align MCO network
adequacy standards with those that apply to QHPs and Medicare Advantage Plans. Given that
most states have experience with assessing private insurance for compliance with the ACAs
network adequacy rules, we believe that this standard can be implemented with relative ease.
1

Milliman, 2013

The alignment of network adequacy standards across Medicaid MCOs, QHPs and Medicare
Advantage Plans will promote greater coverage continuity across public and private insurance,
and create a more navigable health care system for people who are impoverished and whose
income volatility2 renders them more susceptible to churn across multiple types of insurance
coverage. We are confident that these stronger standards can be implemented in a manner that
provides states with enough flexibility to tailor their execution to meet the needs of managed
care beneficiaries within their jurisdictions.
We urge CMS to incorporate a requirement to adopt an Essential Community Provider (ECP)
standard similar to those required of QHPs. At a minimum, we ask that CMS require that MCOs
contract with ECPs as these providers are well-positioned to offer HCV care and treatment, and
the supportive services essential to maximizing a beneficiarys course of treatment. Additionally,
we strongly recommend that CMS consider innovative contracting requirements that have
proven successful with Medicaid programs in Minnesota3 and Colorado4 - states that have
required Medicaid MCOs to contract with all ECPs in their respective jurisdictions.
To promote greater access to care and treatment for people living with HCV, we recommend
that CMS set a national floor standard for maximum time and distance to access providers. This
recommendation is based on a report published by the Kaiser Family Foundation that reviewed
access standards across Medicaid programs. We suggest CMS set an access standard that
ensures access to primary care in urban areas within 30 minutes or 10 miles and for rural areas
within 30 minutes or 30 miles with exceptions for states with documented issues in meeting this
standard. For specialty care, we recommend a general standard of 30 minutes or 30 miles with
exceptions for states with documented issues in meeting this standard. Additionally, we believe
that the maximum wait time to receive a medical visit appointment should not exceed 30 days.
Finally, we also urge that CMS require states to have a meaningful public comment process
before their network adequacy standards are finalized.
PRESCRIPTION DRUG COVERAGE ( 438.3(s))
We support stronger prescription drug coverage standards for beneficiaries enrolled in MCOs.
Unfortunately, recent increases in the number of beneficiaries enrolled in Medicaid have
coincided with the intensified use of prior authorization and other utilization management (UM)
techniques by MCOs. As people living with HCV often manage other comorbid conditions, the

(Dynan, Elmendorf, & Sichel, 2012)

See Minnesota Department of Health. Essential Community Providers. Online at:
http://www.health.state.mn.us/divs/hpsc/mcs/ecpmain.html (accessed online 6/30/15).
4 Colorado Department of Health Care Policy and Financing. Provider Bulletin. Online at:
https://www.colorado.gov/pacific/sites/default/files/Bulletin_0110_B1000274_0.pdf (accessed online
6/30/15).
2
3

speculative use of UM unnecessarily complicates access to treatment. We support inclusion of

the 1927 prescription drug protections for MCOs and proposed change in the prior
authorization decision timeline from three days to 72 hours. Additionally, we urge CMS to curtail
the authority of MCOs to implement UM techniques that erode the effectiveness of these
protections.
We strongly urge CMS to offer clarification on the appropriate use of UM to strengthen the
standards specified in 438.210. This clarification should be informed by national treatment
guidelines, including the Recommendations for Testing, Managing, and Treating Hepatitis,
published by the American Association of for the Study of Liver Diseases and the Infectious
Diseases Society of America. We strongly support a standard that requires UM to ensure that the
amount, duration and scope of services are sufficient to achieve the Medicaid purpose. This
means that UM should be based on a medical review, and supported by clinical
recommendations. We strongly urge CMS to ban UM that prioritizes access to care and
treatment based on severity of condition. Currently, Medicaid MCOs often restrict access to new
curative HCV treatments to beneficiaries who are experiencing stage three or stage four cirrhosis
of the liver. This abhorrent practice is arbitrary and perversely incentivizes people living with HCV
to progress to an advanced status of liver disease or irreparable liver damage before they are
eligible receive access to treatments that have a 90% or greater chance of curing them of a
chronic infectious disease. We believe that this practice is discriminatory and would not be
tolerated if adopted to deny access to treatment for people living with other common chronic
conditions.
The aforementioned must compel CMS to explicitly prohibit UM techniques that are arbitrarily
used to deny or restrict access to care for people with chronic and complex health conditions.
Additional discriminatory practices include the following: requiring step therapy for HCV
treatment; imposing unnecessarily burdensome prior authorization requirements on
medications that are not based on clinical guidelines or recommendations; denying treatment to
individuals living with past or current substance use disorders unless they meet particular
abstinence requirements; and placing arbitrary limitations on access to treatment based on
disease progression.
COVERED OUTPATIENT DRUGS AND FORMULARIES ( 483.3)
We urge CMS to strengthen outpatient drug and formulary standards to ensure access to care
and treatment for Medicaid beneficiaries living with HCV. Unfortunately, reports of Medicaid
MCOs imposing discriminatory outpatient drug and formulary policies that intend to discourage
access to new curative HCV treatments are rampant. These unfounded policies pose a
significant threat to people living with HCV and are incompatible with sensible public health
practice. We welcome the proposed rules clarification that MCOs providing prescription drug
coverage must meet the standards of 1927(k)(2). We also applaud the proposed rules
assertion that state Medicaid programs must cover prescription drugs that are not contractually

mandated to be covered by MCOs. Unfortunately, we believe that these clarifications alone will
not remedy the widespread restrictions that Medicaid MCOs often place on HCV treatment.
These factors compel us to strongly recommend that CMS adopt the following measures:

First, we believe that MCO formularies should be comparable to those of traditional fee-forservice (FFS) Medicaid programs. While we understand that relative to FFS Medicaid, MCOs
are often granted discretion regarding the structure of their benefit designs, we know that in
the absence of additional protections this flexibility frequently leads to unfounded
restrictions on access to new curative HCV treatments. In many states, MCO prior
authorization and other utilization management requirements continue to create barriers to
access to medically recommended treatment regimens. Furthermore, we believe that MCOs
should be able to implement UM practices that are more rigorous than those the FFS
Medicaid program in their jurisdiction.
Next, CMS should prescribe standards for the use of medical need in prior authorization
programs. Prior authorization is almost always inappropriate for HCV given that prescribers
must assess the unique needs and medical history of each affected patient. Further, if prior
authorization is applied then the evaluating professional should be a physician specialist with
expertise in the care and treatment of HCV.
Finally, we believe that CMS should take a more active oversight role for MCO formulary
compositions. We would like to a see final regulatory language that assigns a strong federal
oversight role in this area, with details about how CMS will fulfill this role.

APPEALS ( 438.408)
We support the proposed modifications to the appeals process including: (1) the inclusion of
PAHPS in the appeals process; (2) the requirement that states implement an online system for
tracking and monitoring status of grievances and appeals; and (3) the shortening of the
timeframe for appeal decisions from 45 days to 30 days as well as new expedited review timeline
of 72 hours.
Given the frequency of UM and the complexity of HCV care and treatment, a strong appeals
process is essential to ensure equitable access to services. The number of individuals that churn
between Medicaid and private insurance warrants an appeals standard that, at a minimum,
parallels the appeals process set forth for QHPs, including all of the protections specified in 45
CFR 147.136 - Internal claims and appeals and external review processes. In addition to these
considerations, we strongly urge CMS to set aside the proposed rules requirement that
beneficiaries exhaust the internal appeals process prior to being able to request a State Fair
Hearing. We believe that individuals exhibiting exigent circumstances may require a more
expedient process to have their claim heard.
AVAILABILITY OF SERVICES ( 438.206 & 440.262)
We support the requirement for states to report on a mix of approaches to assess the availability
of services. We believe this evaluation should be available for public inspection on an annual
basis. In an effort to curb access to treatment, many MCOs have placed restrictions on the type

of provider that is authorized to prescribe HCV medications. If MCOs place limitations on

prescriber type, then it must be incumbent upon them to ensure that an adequate number of
allowed prescribers are available to beneficiaries. This adequacy should be based on the
geographic and time considerations noted above. For example, it is untenable that an MCO
would require that an HCV treatment be prescribed by a hepatologist, and then fail to contract
with the adequate number hepatologists needed to serve beneficiaries.
We strongly support the addition of the non-discrimination standard for both Medicaid Managed
Care programs and FFS Medicaid as described in the preamble to the proposed rule. We urge
CMS to strengthen the protection in the rule itself to specify that MCOs must provide access
and delivery of services in a manner that does discriminate due to limited English proficiency,
diverse cultural and ethnic background, disabilities and health status regardless of an enrollees
gender, sexual orientation and gender identify.
COVERAGE AND AUTHORIZATION OF SERVICES AND CONTINUATION OF BENEFITS WHILE APPEALS
AND HEARINGS ARE PENDING ( 438.210 & .420)
We support the proposed rules intent to modernize standards around instances where a
Medicaid program or state desires to reduce or eliminate treatments. It is in the best interest of
beneficiaries to maintain access to essential medications while appealing a reduction in or
termination of coverage. We strongly recommend that CMS specify that coverage of HCV
medications cannot be reduced or eliminated once a beneficiary has begun and successfully
adhered to a curative treatment regimen. Without this added protection, beneficiaries risk losing
access to their current treatment and may become clinically ineligible to use the same drug or
other treatments in the future.
We welcome the application of CMS seminal requirement that treatments be reasonable in
amount, duration, and scope.. While we recognize that compliance with this standard will be
assessed by state Medicaid programs, we request that CMS retain the right to assess MCO
compliance and intervene if necessary.
ASSURANCES OF ADEQUATE CAPACITY AND SERVICES ( 438.207)
We strongly support the requirement that MCOs submit documentation attesting to their
network adequacy, and geographic distribution of providers. We recommend that CMS require
this information to be published on each MCOs website. We also agree with the
recommendation that MCOs submit updated documentation annually, or if there is a substantive
shift in capacity that may affect service delivery.

CMS REVIEW AND APPROVAL OF STATE MCO CONTRACTS ( 438.3(a))

We believe that Medicaid program and MCO compliance with beneficiary protections must be
verified by CMS. We ask for additional oversight and approval of MCO contacts. Furthermore, we
strongly urge CMS to apply the nondiscrimination standards specified in 1557 of ACA to MCOs.
We also believe that future federal regulation implementing 1557 should address Medicaid
programs and MCOs. Finally, we ask that CMS produce technical assistance resources, inclusive
of explicit guidance and examples that offer clarity on the types of practices that constitute
discrimination.
TRANSITION STANDARDS ( 438.62)
Given that many Medicaid programs and MCOs contract with a variety of third-party vendors to
provide services to beneficiaries, we strongly support transition standards that ensure continuity
of coverage. We support the requirements included in the proposed rule to ensure access to
providers and treatment regimens during transition from one Medicaid delivery system to
another. We also urge CMS to clarify that these transition standards also apply when
beneficiaries are moving from a QHP to a Medicaid delivery system.
ENROLLMENT PROTECTIONS ( 438.54)
We strongly support beneficiary protections that empower consumers to make an informed
choice prior to enrolling into an MCO plan. We believe that the proposed rule should explicitly
mention that where Medicaid programs offer both a traditional FFS model and MCOs, a
beneficiary is required to choose one or the other. Prioritizing active enrollment instead of
random assignment offers beneficiaries the opportunity to make informed choices.
We strongly support the proposal to develop a Beneficiary Support System as proposed in
438.71. This system should include resources on how to access supportive services not covered
by Medicaid including information on federally qualified health centers, free clinics, and social
services available in the jurisdiction. We also support the proposed rules position on autoassignment and the intent to work to preserve beneficiary relationships with providers.
INFORMATION REQUIREMENTS ( 438.10)
We believe the proposed rules information requirements must be strengthened in order to
support informed consumer choice of MCOs. Beneficiaries should be able to review an MCOs
full formulary, any prior authorization or other UM, and associated out-of-pocket costs prior to
enrollment in order to make an informed decision to enroll in the plan that will best meet their
care and treatment needs. We strongly urge that CMS require MCOs to provide complete and
accurate formulary information, including all out-of-pocket costs. This information must be
accessible to those comparing MCOs (in jurisdictions that have more than one MCO).
Additionally, formularies should be updated monthly.

We support the proposal to require MCOs to update their provider directories at least monthly
as stated in the preamble ideally the updates would be closer to real time, e.g., on a weekly
basis. In addition, we urge you to require plans to:
Identify Essential Community Providers in the directories, including by type
Indicate the date of the last update to the directory in an easily accessible location
Include a search function for providers by name or specialty as suggested in the FY 2015
letter to issuers
Additionally we urge CMS to combine subsections 438.3(d)(3) (MCOs will not, on the basis of
health status or need for health care services, discriminate against individuals eligible to enroll)
and 438.3(d)(4) (MCOs will not discriminate against individuals eligible to enroll on the basis of
race, color, national origin, sex, sexual orientation gender identity, or disability and will not use
any policy or practice that has the effect of discriminating on the basis of race, color, or national
origin, sex, sexual orientation, gender identity or disability). This would align Medicaid MCO
standards with those found in 1557 of the ACA. The appeals process should also be readily
available to beneficiaries.
PREVENTIVE SERVICES ( 438.2, 3, 10, 66 & 108)
We are very concerned that the proposed rule inadequately protects beneficiary rights to access
routine HCV testing. Recognizing the urgency of the epidemic, the United State Preventive
Services Task Force (USPSTF) assigned a B grade for HCV testing. The ACA requires that
services assigned an A or B grade are required to be covered in Alternative Benefit Plans
(ABPs) for the expansion population. We believe that the best way to save future Medicaid
program resources spend on HCV is to maximize prevention coverage opportunities. To this end,
we propose the following considerations to strengthen the prevention services standards
outlined in the proposed rule:

CMS should define preventive services and specify alignment with USPSTF standards in MCO
contracting.
Furthermore, in 438.3, CMS should require MCOs to provide for coverage of preventive
services as required by the ACA.
Finally, 438.66 should be amended to require state Medicaid programs to monitor MCO
compliance with the requirement to provide preventive services without cost-sharing.

ACTUARARIAL SOUNDNESS ( 438.4(b)(2))

We appreciate that the proposed rule draws a connection between sensible reimbursement
structures and the extent to which services are available. A lack of actuarially sound
reimbursement compromises the availability of services to beneficiaries and impacts the extent
to which providers are willing to contract with Medicaid and MCOs. In a recent decision, the
United States Supreme Court held that providers and beneficiaries may not turn to the courts to

enforce the minimum legal terms of the Medicaid statute.5 This decision indicates the need for
increased federal oversight of this critical component of the managed care system.
Finally, we support the proposed rules stance on allowing MCOs to implement value-based
purchasing models, participate in multi-payer delivery systems and to adopt provider payment
incentives. While this flexibility is essential to modernizing Medicaid, we ask that CMS monitor
MCOs that adopt these reimbursement models for compliance with beneficiary protections. New
reimbursement models should not impact the extent to which beneficiaries access the benefits
for which they are eligible.

Thank you for the opportunity to offer comments to this proposed rule. Please contact Xavior
Robinson with the National Alliance of State and Territorial AIDS Directors (NASTAD) at
xrobinson@nastad.org if you have any questions or comments.
Sincerely,
Caring Ambassadors Program, Inc. | Hepatitis C Mentor Support Group (HCMSG) | National
Alliance of State and Territorial AIDS Directors (NASTAD) | National Viral Hepatitis Roundtable |
One in Four Chronic Health | Project Inform | Robert Gish Consultants, LLC

Armstrong v. Exceptional Child Center, Inc., 135 S.Ct. 939 (2015).